Clinical Study of Double-Endoscopic Combined With Minimally Invasive Treatment for Early Gastric Cancer at Clinical Stage T1b

NCT ID: NCT06934824

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-01-01

Brief Summary

For patients diagnosed with early gastric cancer involving submucosal invasion, super-ESD indications, or lymph node metastasis, a combination of preoperative endoscopic ultrasound and abdominal contrast-enhanced CT was utilized to ascertain the depth of tumor invasion and to identify any suspicious metastatic lymph nodes in the vicinity of the stomach. Subsequently, a local full-thickness resection, coupled with or followed by individualized precise lymph node dissection, was conducted to fulfill the following objectives: ① To investigate the safety, feasibility, and efficacy of local resection for patients meeting super-ESD criteria; ② To offer a clinical foundation for the individualized and precise lymph node dissection treatment of early gastric cancer.

Conditions

Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

Patients in group A-No lymph node metastasis, who underwent simple Double-Endoscopic Combined with local full-thickness resection.

Group Type: EXPERIMENTAL

Sixty patients with early gastric cancer in stage T1bN0-1M0 were divided into Group A-N0 and Group B-N + according to the presence or absence of lymph node metastasis. When the enrolled patients und

Intervention Type: PROCEDURE

Patients in group A-No lymph node metastasis, who underwent simple Double-Endoscopic Combined with local full-thickness resection.

Patients in group B-imaging examination showed lymph node metastasis. patients were randomly divided into Group N + a and Group N + b.

Group N + a: Local full-thickness gastric wall and lymph nodes dissection on D1 or D1 + were performed with Double-Endoscopic Group N + b: Traditional standard surgical gastrectomy and D1 or D1 + lymph nodes dissection was performed .

Group B

Patients in group B-imaging examination showed lymph node metastasis. patients were randomly divided into Group N + a and Group N + b.

Group N + a: Local full-thickness gastric wall and lymph nodes dissection on D1 or D1 + were performed with Double-Endoscopic Group N + b: Traditional standard surgical gastrectomy and D1 or D1 + lymph nodes dissection was performed .

Group Type: EXPERIMENTAL

Sixty patients with early gastric cancer in stage T1bN0-1M0 were divided into Group A-N0 and Group B-N + according to the presence or absence of lymph node metastasis. When the enrolled patients und

Intervention Type: PROCEDURE

Patients in group A-No lymph node metastasis, who underwent simple Double-Endoscopic Combined with local full-thickness resection.

Patients in group B-imaging examination showed lymph node metastasis. patients were randomly divided into Group N + a and Group N + b.

Group N + a: Local full-thickness gastric wall and lymph nodes dissection on D1 or D1 + were performed with Double-Endoscopic Group N + b: Traditional standard surgical gastrectomy and D1 or D1 + lymph nodes dissection was performed .

Interventions

Sixty patients with early gastric cancer in stage T1bN0-1M0 were divided into Group A-N0 and Group B-N + according to the presence or absence of lymph node metastasis. When the enrolled patients und

Patients in group A-No lymph node metastasis, who underwent simple Double-Endoscopic Combined with local full-thickness resection.

Patients in group B-imaging examination showed lymph node metastasis. patients were randomly divided into Group N + a and Group N + b.

Group N + a: Local full-thickness gastric wall and lymph nodes dissection on D1 or D1 + were performed with Double-Endoscopic Group N + b: Traditional standard surgical gastrectomy and D1 or D1 + lymph nodes dissection was performed .

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Age 18-70 years old;

2. Endoscopic pathological diagnosis: adenocarcinoma;

3. Enhanced abdominal CT combined with endoscopic ultrasound clinical staging: T1bN0-1M0.

4. Has not received other treatment;

5. No other serious comorbidities;

6. Agree to participate in the study and sign the informed consent form.

Exclusion Criteria

1. Pregnant or breastfeeding women

2. History of previous abdominal surgery

3. History of other previous malignancies

4. Can patients with severe heart, lung, brain diseases tolerate surgical treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Qun Zhao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Qun Zhao, Ph.D

Role: CONTACT

zhaoqun@hebmu.edu.cn

China+8613930162111

Gang pei Yang, Master's degree

Role: CONTACT

China+8613731153070

Other Identifiers

FUTURE11

Identifier Type: -

Identifier Source: org_study_id